digital health application

数字健康应用
  • 文章类型: Systematic Review
    近年来,mHealth应用程序的数量迅速增加。文献表明,采用mHealth应用程序存在许多问题和障碍,包括有效性等问题,可用性,以及数据隐私和安全。持续的质量评估和保证体系可能有助于克服这些障碍。这次范围审查的目的是整理有关mHealth应用程序的质量评估工具和质量保证体系的文献,编译工具的组件,并得出总体质量尺寸,这可能与mHealth应用程序的持续质量评估相关。
    文献检索在Medline进行,EMBASE和PsycInfo。包括英语或德语的文章,如果它们包含有关发展的信息,应用程序,或验证mHealth应用程序的质量评估或质量保证的通用概念。筛选和提取由两名研究人员独立进行。提取确定的质量标准和方面,并将其聚类为质量维度。
    共有70种出版物符合纳入标准。包含的出版物包含有关五个质量保证系统的信息,以及用于mHealth应用程序的24个质量评估工具。在这29个系统/工具中,开发了8个用于评估特定疾病的mHealth应用程序,16个用于评估所有健康领域的mHealth应用程序,另外5个不限于健康应用程序。提取确定的质量标准和方面,并将其分为总共14个质量维度,即“信息和透明度”,“有效性和(添加)值”,“(医疗)安全”,“互操作性和兼容性”,\"实际\",\"订婚\",“数据隐私和数据安全”,“可用性和设计”,\"技术\",“组织方面”,“社会方面”,“法律方面”,“公平与平等”,和“成本(-有效性)”。
    此范围审查提供了对现有质量评估和保证体系的广泛概述。所包含的许多工具仅涵盖几个方面和方面,因此无法进行全面的质量评估或质量保证。我们的发现可以为mHealth应用程序的持续质量评估和保证系统的开发做出贡献。
    https://www.researchprotocols.org/2022/7/e36974/,国际注册报告标识符,IRRID(DERR1-10.2196/36974)。
    UNASSIGNED: The number of mHealth apps has increased rapidly during recent years. Literature suggests a number of problems and barriers to the adoption of mHealth apps, including issues such as validity, usability, as well as data privacy and security. Continuous quality assessment and assurance systems might help to overcome these barriers. Aim of this scoping review was to collate literature on quality assessment tools and quality assurance systems for mHealth apps, compile the components of the tools, and derive overarching quality dimensions, which are potentially relevant for the continuous quality assessment of mHealth apps.
    UNASSIGNED: Literature searches were performed in Medline, EMBASE and PsycInfo. Articles in English or German language were included if they contained information on development, application, or validation of generic concepts of quality assessment or quality assurance of mHealth apps. Screening and extraction were carried out by two researchers independently. Identified quality criteria and aspects were extracted and clustered into quality dimensions.
    UNASSIGNED: A total of 70 publications met inclusion criteria. Included publications contain information on five quality assurance systems and further 24 quality assessment tools for mHealth apps. Of these 29 systems/tools, 8 were developed for the assessment of mHealth apps for specific diseases, 16 for assessing mHealth apps for all fields of health and another five are not restricted to health apps. Identified quality criteria and aspects were extracted and grouped into a total of 14 quality dimensions, namely \"information and transparency\", \"validity and (added) value\", \"(medical) safety\", \"interoperability and compatibility\", \"actuality\", \"engagement\", \"data privacy and data security\", \"usability and design\", \"technology\", \"organizational aspects\", \"social aspects\", \"legal aspects\", \"equity and equality\", and \"cost(-effectiveness)\".
    UNASSIGNED: This scoping review provides a broad overview of existing quality assessment and assurance systems. Many of the tools included cover only a few dimensions and aspects and therefore do not allow for a comprehensive quality assessment or quality assurance. Our findings can contribute to the development of continuous quality assessment and assurance systems for mHealth apps.
    UNASSIGNED: https://www.researchprotocols.org/2022/7/e36974/, International Registered Report Identifier, IRRID (DERR1-10.2196/36974).
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  • 文章类型: Journal Article
    背景:医疗保健的数字化导致移动健康(mHealth)应用程序的采用和使用稳步增加。德国是世界上第一个通过法定健康保险支付mHealth应用程序费用的国家。尽管详细讨论了mHealth应用程序的好处,问题和障碍的各个方面很少被研究。
    目的:本范围审查旨在对与使用mHealth应用程序相关的问题和障碍的证据进行映射和分类。
    方法:在MEDLINE中进行了系统搜索,Embase,和PsycINFO数据库。在JMIR出版物和相关国际组织的网站上进行了其他搜索。纳入标准是涉及类似于德国医疗保健系统批准的应用程序的出版物,解决与使用mHealth应用程序相关的问题和障碍的出版物,以及在2015年1月1日至2021年6月8日之间发表的文章。研究选择由2名评审员进行。该手稿是根据PRISMA-ScR(系统审查的首选报告项目和范围审查的荟萃分析扩展)清单起草的。使用MAXQDA(VERBISoftwareGmbH)对所包含的出版物进行分析,并对问题和障碍进行分类。
    结果:数据库搜索确定了1479种出版物。在1479份出版物中,21人(1.42%)符合纳入标准。JMIR出版物中的引文搜索和搜索还包括了另外8种出版物。对确定的出版物进行了问题和障碍分析。问题和障碍被分为10类(“有效性,\"\"可用性,\"\"技术,\"\"使用和坚持,\"\"数据隐私和安全,\“\”病人-医生关系,“\”知识和技能,\"\"个性,\"\"实施,\"和\"费用\")。最常提到的类别是使用和依从性(例如,将应用程序融入日常生活或退出使用;n=22)和可用性(例如,易于使用和设计;n=19)。
    结论:搜索发现了mHealth应用程序中的各种问题和障碍。尽管经常研究应用程序级别的问题(例如可用性),系统层面的问题处理得相当模糊。为了确保mHealth应用程序的最佳使用和护理,必须考虑所有类型的问题和障碍。因此,研究人员和政策制定者应该特别关注这个问题,以确定质量保证的需求。
    RR2-10.2196/32702。
    The digitization of health care led to a steady increase in the adoption and use of mobile health (mHealth) apps. Germany is the first country in the world to cover the costs of mHealth apps through statutory health insurance. Although the benefits of mHealth apps are discussed in detail, aspects of problems and barriers are rarely studied.
    This scoping review aimed to map and categorize the evidence on problems and barriers related to the use of mHealth apps.
    Systematic searches were conducted in the MEDLINE, Embase, and PsycINFO databases. Additional searches were conducted on JMIR Publications and on websites of relevant international organizations. The inclusion criteria were publications dealing with apps similar to those approved in the German health care system, publications addressing problems and barriers related to the use of mHealth apps, and articles published between January 1, 2015, and June 8, 2021. Study selection was performed by 2 reviewers. The manuscript was drafted according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist. The analysis of the included publications and categorization of problems and hurdles were performed using MAXQDA (VERBI Software GmbH).
    The database search identified 1479 publications. Of the 1479 publications, 21 (1.42%) met the inclusion criteria. A further 8 publications were included from citation searching and searching in JMIR Publications. The identified publications were analyzed for problems and barriers. Problems and barriers were classified into 10 categories (\"validity,\" \"usability,\" \"technology,\" \"use and adherence,\" \"data privacy and security,\" \"patient-physician relationship,\" \"knowledge and skills,\" \"individuality,\" \"implementation,\" and \"costs\"). The most frequently mentioned categories were use and adherence (eg, incorporating the app into daily life or dropouts from use; n=22) and usability (eg, ease of use and design; n=19).
    The search identified various problems and barriers in the context of mHealth apps. Although problems at the app level (such as usability) are studied frequently, problems at the system level are addressed rather vaguely. To ensure optimal use of and care with mHealth apps, it is essential to consider all types of problems and barriers. Therefore, researchers and policy makers should have a special focus on this issue to identify the needs for quality assurance.
    RR2-10.2196/32702.
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  • 文章类型: Journal Article
    背景:尽管有成千上万的心理健康应用程序,2个应用程序,顶部空间和平静,占据了市场的很大一部分。这两个正念和冥想应用程序已经达到了数千万的活跃用户。引导消费者,临床医生,和研究人员,我们对顶空和镇静的随机对照试验(RCTs)进行了系统评价.
    目的:我们的研究旨在评估干预效果,偏见的风险,以及“顶空与平静”证据基础中的利益冲突(COIs),我们搜索时最受欢迎的两个心理健康应用程序。
    方法:为了确定研究,我们搜索了学术数据库(谷歌学者,MEDLINE,和PsycINFO)以及2021年5月的HeadspaceandCalm网站,通过原始数据收集进行HeadspaceandCalm测试功效的RCT,在同行评审期刊上以英文发表。对于每一项研究,我们编码了(1)研究特征(例如,参与者,样本量,和结果衡量标准),(2)干预特征(例如,免费与付费版本的应用程序和预期的应用程序使用频率),(3)所有研究结果,(4)偏差变量的Cochrane风险,和(5)COI变量(例如,是否存在预注册以及是否存在涉及公司的COI声明)。
    结果:我们确定了14个顶空RCT和1个CalmRCT。总的来说,93%(13/14)的顶部空间RCTs和100%(1/1)的CalmRCTs招募了来自非临床人群的参与者。通常测量正念的研究,幸福,压力,抑郁症状,和焦虑症状。在75%的评估结果的研究中,顶空使用改善了抑郁症。正念的发现好坏参半,幸福,压力,和焦虑,但至少40%的研究显示这些结局均有所改善.研究通常不足以检测“小”或“中”效应大小。此外,50%(7/14)的顶部空间RCT和0%(0/1)的CalmRCT报告了涉及顶部空间或Calm(公司)的COI。最常见的COI是为参与者免费提供高级应用程序访问的应用程序公司,尤其是,14%(2/14)的顶部空间RCT报告顶部空间员工参与研究设计,执行,和数据分析。只有36%(5/14)的顶部空间随机对照试验被预先登记,并且Calm的1个RCT没有预先注册。
    结论:顶空的实证研究似乎很有希望,而没有关于Calm的随机试验。这项研究的局限性包括由于缺乏研究Calm的RCT以及依赖作者报告来评估COIs而无法比较顶部空间和Calm。在确定心理健康应用程序是否具有高质量时,应确保识别高质量的应用程序并评估其有效性和调查人员的COIs。
    BACKGROUND: Although there are thousands of mental health apps, 2 apps, Headspace and Calm, claim a large percentage of the marketplace. These two mindfulness and meditation apps have reached tens of millions of active users. To guide consumers, clinicians, and researchers, we performed a systematic review of randomized controlled trials (RCTs) of Headspace and Calm.
    OBJECTIVE: Our study aimed to evaluate intervention efficacy, risk of bias, and conflicts of interest (COIs) in the evidence base for Headspace and Calm, the two most popular mental health apps at the time of our search.
    METHODS: To identify studies, we searched academic databases (Google Scholar, MEDLINE, and PsycINFO) and the websites of Headspace and Calm in May 2021 for RCTs of Headspace and Calm testing efficacy via original data collection, published in English in peer-reviewed journals. For each study, we coded (1) study characteristics (eg, participants, sample size, and outcome measures), (2) intervention characteristics (eg, free vs paid version of the app and intended frequency of app usage), (3) all study outcomes, (4) Cochrane risk of bias variables, and (5) COI variables (eg, presence or absence of a preregistration and the presence or absence of a COI statement involving the company).
    RESULTS: We identified 14 RCTs of Headspace and 1 RCT of Calm. Overall, 93% (13/14) of RCTs of Headspace and 100% (1/1) of RCTs of Calm recruited participants from a nonclinical population. Studies commonly measured mindfulness, well-being, stress, depressive symptoms, and anxiety symptoms. Headspace use improved depression in 75% of studies that evaluated it as an outcome. Findings were mixed for mindfulness, well-being, stress, and anxiety, but at least 40% of studies showed improvement for each of these outcomes. Studies were generally underpowered to detect \"small\" or \"medium\" effect sizes. Furthermore, 50% (7/14) of RCTs of Headspace and 0% (0/1) of RCTs of Calm reported a COI that involved Headspace or Calm (the companies). The most common COI was the app company providing premium app access for free for participants, and notably, 14% (2/14) of RCTs of Headspace reported Headspace employee involvement in study design, execution, and data analysis. Only 36% (5/14) of RCTs of Headspace were preregistered, and the 1 RCT of Calm was not preregistered.
    CONCLUSIONS: The empirical research on Headspace appears promising, whereas there is an absence of randomized trials on Calm. Limitations of this study include an inability to compare Headspace and Calm owing to the dearth of RCTs studying Calm and the reliance on author reports to evaluate COIs. When determining whether or not mental health apps are of high quality, identification of high-quality apps and evaluation of their effectiveness and investigators\' COIs should be ensured.
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  • 文章类型: Journal Article
    背景:世界各地,移动健康(mHealth)应用程序的开发和使用正在增加。虽然应用程序提供了许多改善医疗保健的机会,与传统医疗保健服务有很大不同的相关问题。需要对mHealth应用程序的质量进行进一步调查以解决这些问题。
    目的:本研究旨在确定和绘制有关mHealth应用程序的质量评估和质量保证及其向mHealth应用程序的持续质量保证的可转移性的研究。
    方法:范围审查将遵循已发布的范围研究方法学框架,以及范围审查标准的系统审查和Meta分析扩展的首选报告项目。电子数据库(Medline,EMBASE,和PsycINFO),相关文章的参考列表,将搜索相关机构的网站。两名审稿人将独立评估文章的资格。因此,2阶段(标题和摘要,其次是全文)进行筛选过程。质量管理体系和质量评估工具将被分析并包括在我们的审查中。特别关注的是质量尺寸。
    结果:本范围审查概述了现有证据,并确定了有关mHealth应用程序持续质量评估的研究差距。因此,可以确定相关的质量维度和标准,并确定其开发mHealth应用程序持续质量保证体系的资格和相关性。我们的结果计划提交给索引,2022年下半年的同行评审期刊。
    结论:这是关于mHealth应用程序持续质量保证的首次综述。我们的研究结果将用于德国联邦联合委员会资助的“数字健康应用的持续质量保证”(“QuaSiApps”)项目。
    DERR1-10.2196/36974。
    BACKGROUND: All over the world, development and usage of mobile health (mHealth) apps is increasing. While apps offer numerous opportunities to improve health care, there are associated problems that differ significantly from those of traditional health care services. Further investigations on the quality of mHealth apps are needed to address these problems.
    OBJECTIVE: This study aims to identify and map research on quality assessment and quality assurance of mHealth apps and their transferability to continuous quality assurance of mHealth apps.
    METHODS: The scoping review will follow published methodological frameworks for scoping studies as well as Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews criteria. Electronic databases (Medline, EMBASE, and PsycINFO), reference lists of relevant articles, and websites of relevant institutions will be searched. Two reviewers will independently assess eligibility of articles. Therefore, a 2-stage (title and abstract, followed by full text) screening process was conducted. Quality management systems and quality assessment tools will be analyzed and included in our review. Particular focus is placed on quality dimensions.
    RESULTS: This scoping review provides an overview of the available evidence and identifies research gaps regarding continuous quality assessment of mHealth apps. Thereby, relevant quality dimensions and criteria can be identified and their eligibility and relevance for the development of a continuous quality assurance system of mHealth apps can be determined. Our results are planned to be submitted to an indexed, peer-reviewed journal in the second half of 2022.
    CONCLUSIONS: This is the first review in the context of continuous quality assurance of mHealth apps. Our results will be used within the research \"Continuous quality assurance of Digital Health Applications\" (\"QuaSiApps\") project funded by the German Federal Joint Committee.
    UNASSIGNED: DERR1-10.2196/36974.
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  • 文章类型: Journal Article
    背景:移动健康(mHealth)应用程序的使用在全球范围内迅速增加。越来越多的机构和组织制定法规和准则,以实现基于证据的安全使用。在德国,满足预定义标准的mHealth应用程序(DigitaleGesundheitsanwendungen[DiGA])可以规定并由德国法定健康保险计划报销。由于DiGA分布的增加,问题和障碍应该得到特别关注。
    目的:本研究旨在确定与使用符合DiGA标准的mHealth应用程序相关的问题和障碍。
    方法:本范围审查将遵循已发布的方法学框架和PRISMA-Scr(系统审查的首选报告项目和范围审查的Meta扩展分析)标准。电子数据库(MEDLINE,EMBASE,PsycINFO,和JMIR),相关文章的参考列表,和灰色文献来源将被搜索。两名审稿人将通过两个阶段(标题和摘要以及全文)筛选过程来评估文章的资格。本研究仅包括与满足DiGA标准的mHealth应用程序相关的问题和障碍。将使用MAXQDA对确定的研究进行分类和分析。
    结果:本范围审查概述了现有证据,并确定了与DiGA相关的问题和障碍的研究空白。计划将结果提交给索引,2022年第一季度的同行评审期刊。
    结论:这是第一次审查,以确定与使用mHealth应用程序符合德国对DiGA的定义有关的问题和障碍。然而,这些发现也可以应用于其他环境和医疗保健系统。
    UNASSIGNED:DERR1-10.2196/32702。
    BACKGROUND: The use of mobile health (mHealth) apps is increasing rapidly worldwide. More and more institutions and organizations develop regulations and guidelines to enable an evidence-based and safe use. In Germany, mHealth apps fulfilling predefined criteria (Digitale Gesundheitsanwendungen [DiGA]) can be prescribed and are reimbursable by the German statutory health insurance scheme. Due to the increasing distribution of DiGA, problems and barriers should receive special attention.
    OBJECTIVE: This study aims to identify the relevant problems and barriers related to the use of mHealth apps fulfilling the criteria of DiGA.
    METHODS: This scoping review will follow published methodological frameworks and the PRISMA-Scr (Preferred Reporting Items for Systematic Reviews and Meta-analyses Extension for Scoping Reviews) criteria. Electronic databases (MEDLINE, EMBASE, PsycINFO, and JMIR), reference lists of relevant articles, and grey literature sources will be searched. Two reviewers will assess the eligibility of the articles by a two-stage (title and abstract as well as full text) screening process. Only problems and barriers related to mHealth apps fulfilling the criteria of DiGA are included for this research. The identified studies will be categorized and analyzed with MAXQDA.
    RESULTS: This scoping review gives an overview of the available evidence and identifies research gaps regarding problems and barriers related to DiGA. The results are planned to be submitted to an indexed, peer-reviewed journal in the first quarter of 2022.
    CONCLUSIONS: This is the first review to identify the problems and barriers related to the use of mHealth apps fulfilling the German definition of DiGA. Nevertheless, the findings can be applied to other contexts and health care systems as well.
    UNASSIGNED: DERR1-10.2196/32702.
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  • 文章类型: Journal Article
    Germany is the first country worldwide that has introduced a digital care act as an incentive system to enhance the use of digital health devices, namely health apps and wearables, among its population. The act allows physicians to prescribe statutory financed and previously certified health apps and wearables to patients. This initiative has the potential to improve treatment quality through better disease management and monitoring.
    The aim of this paper was to outline the key concepts related to the potential risks and benefits discussed in the current literature about health apps and wearables. Furthermore, this study aimed to answer the research question: Which risks and benefits may result from the implementation of the digital care act in Germany?
    We conducted the scoping study by searching the databases PubMed, Google Scholar, and JMIR using the keywords health apps and wearables. We discussed 55 of 136 identified articles published in the English language from 2015 to March 2019 in this paper using a qualitative thematic analysis approach.
    We identified four key themes within the articles: Effectivity of health apps and wearables to improve health; users of health apps and wearables; the potential of bring-your-own, self-tracked data; and concerns and data privacy risks. Within these themes, we identified three main stages of benefits for the German health care system: Usage of health apps and wearables; continuing to use health apps and wearables; and sharing bring-your-own; self-tracked data with different agents in the health care sector.
    The digital care act could lead to an improvement in treatment quality through better patient monitoring, disease management, personalized therapy, and better health education. However, physicians should play an active role in recommending and supervising health app use to reach digital-illiterate or health-illiterate people. Age must not be an exclusion criterion. Yet, concerns about data privacy and security are very strong in Germany. Transparency about data processing should be provided at all times for continuing success of the digital care act in Germany.
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